Cleared Traditional

K162332 - Nexcore GI Insufflator

K162332 is an FDA 510(k) clearance for Nexcore GI Insufflator, manufactured by Nexcore Technology, LLC. The device is a Class 2 Gastroenterology & Urology device with product code FCX cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K162332 · Nexcore Technology, LLC · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2016
Decision
41d
Days
Class 2
Risk

K162332 is an FDA 510(k) clearance for the Nexcore GI Insufflator. Classified as Insufflator, Automatic Carbon-dioxide For Endoscope (product code FCX), Class II - Special Controls.

Submitted by Nexcore Technology, LLC (Winchester, US). The FDA issued a Cleared decision on September 29, 2016 after a review of 41 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Nexcore Technology, LLC devices

FDA 510(k) Submission Details - K162332

510(k) Number K162332 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 2016
Decision Date September 29, 2016
Days to Decision 41 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
89d faster than avg
Panel avg: 130d · This submission: 41d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

FCX Device Classification - Class 2, Special Controls

Product Code FCX Insufflator, Automatic Carbon-dioxide For Endoscope
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - FCX Insufflator, Automatic Carbon-dioxide For Endoscope

All 15
Devices cleared under the same product code (FCX) and FDA review panel - the closest regulatory comparables to K162332.
CO2mbiLED
K201096 · KARL STORZ Endoscopy-America, Inc. · Jun 2020
BAROnova Insufflation System, BAROnova Accessory Kit
K190985 · Baronova, Inc. · May 2019
FUJIFILM Endoscopic CO2 Regulator GW-100
K180711 · Fujifilm Corporation · May 2018
FUJIFILM ENDOSCOPIC CO2 REGULATOR
K133976 · Fujifilm Medical System U.S.A., Inc. · Sep 2014
ENDOSCOPIC INSUFFLATION UNIT, MODEL XECR-2
K063786 · Olympus Medical Systems Corporation · Mar 2007
E-Z-EM ENDOSCOPIC CO2 REGULATOR
K053008 · E-Z-Em, Inc. · Dec 2005